Tissue in ResearchSafe storage, use, transfer, ethics and regulation

Summary

Research using stored tissue poses a number of ethical issues, for individual sample sources, for researchers and for society. The ethical considerations at stake include maximising the benefits of research for the good of society; the consent of the individuals whose tissue is stored and used; privacy of the data...read moreassociated with tissue; and ways of assuring proper use when tissue is transferred across borders. This must all be taken into account, whilst ensuring that local legislation governing tissue use is adhered to, this may of course vary between countries.

Legislation governing tissue research
How tissue use is governed by national legislation must of course be the first consideration prior to any tissues being used in medical research. The national or international laws must be obeyed when planning research, especially projects which may involve international collaboration. Research institutes often have their own experts whose role is to ensure research at their facility follows the national legislation. Indeed institutes may impose their own stricter regulations on top of the national legislation to ensure there is no question of any wrong doing and that every effort is made for all research to be of a high ethical standard.

Storage
Regarding storage, there are issues about how the tissue is initially acquired, e.g. what kind of consent has been gained from the donors; how it is stored and who has access to it. There are concerns, in some cultures more than others, about human tissues being taken overseas, so there are issues not only about how tissue is stored, but where. Concerns about privacy have proliferated in the last few years, especially when tissue is associated with health and /or lifestyle information. It is increasingly clear that in the context of genetic research, for example, privacy is impossible to guarantee completely.

Use
Potential uses of human tissue include transplantation (e.g. for fetal tissue transplants), pharmaceutical research and genetic research. So tissue may be stored for clinical as well as research use.

Transfer
It is argued that the international transfer and sharing of human tissue and data is essential to ensure the success of biomedical research and ultimately to provide the basis for improved health care for the future. Where tissue is transferred internationally, however, there are questions about how proper use can be assured, because different values may prevail in different social and cultural contexts. Should this be done by means of contracts between the parties, or is regulation the best option? At the level of the European Union parameters have been established for transfer of tissue and data across the Union and beyond. Discussion is ongoing on all these issues.